MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. CLEANER ROTATIONAL THROMBECTOMY SYSTEM

Catalog Number 700015

Device Problem Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/14/2017

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record was performed and no similar concerns were found.This product is purchased fully packaged from a supplier.Supplier corrective action request (scar) 1470 will document the root causes per the supplier's evaluation and any corrective actions.A follow-up report will be submitted with the supplier's evaluation and conclusions.

Event Description

When the catheter was removed from the patient, the white tip was missing and appeared in the filter tubing for perfusion.The original intended procedure was an angiovac ivc thrombectomy.

Manufacturer Narrative

The supplier provided their evaluation of the issue: a device history record review was performed.The review of the lot record documentation indicated that the product was manufactured according to the established processes and procedures.There were no related non-conformances or deviations noted on the specified lots, and the associated operators were trained to the most recent document revisions based on the date of manufacture.A tip is over molded onto the stainless steel tip by the supplier, and there was no damage to the mold indicating that the wire had been correctly loaded into the tool.Six samples were tested in an attempt to recreate the separated tip issue using hand pressure.Hand pressure was placed on the tips at various angles while holding the tipped end of the guidewire.This technique was used to place as much force on the machined tip in an attempt to separate.No tips separated during the testing.Another attempt was made to separate the tip by pushing the tip against a flat hard surface (table surface).The machined tip did bend at the base of the tip, but the tip did not separate during this test.A definitive root cause of the separated tip could not be determined.The investigation of the molding and assembly process could not reproduce the issue observed.

• Brand Name: CLEANER ROTATIONAL THROMBECTOMY SYSTEM
• Type of Device: ROTATIONAL THROMBECTOMY SYSTEM
• Manufacturer (Section D): ARGON MEDICAL DEVICES INC.; 1445 flat creek road; athens TX 75751
• Manufacturer (Section G): ARGON MEDICAL DEVICES INC.
• Manufacturer Contact: gail smith ; 1445 flat creek road; athens, TX 75751 ; 2144368995
• MDR Report Key: 6777396
• MDR Text Key: 82957403
• Report Number: 1625425-2017-00101
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141617
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/05/2020
• Device Catalogue Number: 700015
• Device Lot Number: REF170021/1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other